RealLine EGFR

RUO

Product name Cat.No. Packsize
RealLine EGFR Detect 2M, Kit for Real Time PCR
[PDS]
MED21801 12 rcs
RealLine EGFR Detect 2M, Kit for Real Time PCR
[PDS]
MED21810 36 rcs
RealLine EGFR Detect 7R, Kit for Real Time PCR
[PDS]
MED21811 12 rcs
RealLine EGFR Detect 7R, Kit for Real Time PCR
[PDS]
MED21812 36 rcs
EGFR Standard DNA Kit
[PDS]
MED32401 8 x 100 ng

Non-small cell lung cancer (NSCLC) is the most common type of the lung cancer. Activating somatic mutations within the tyrosin kinase (TK) domain in the epidermal growth factor receptor (EGFR) protein are associated with sensitivity of tumors to EGFR-TK inhibitors. Most of these mutations (~90%) occur as either in-frame microdeletions that affect codons 746-750 in exon 19 (del19), or a missense mutation L858R in exon 21 of the EGFR gene. In addition rare activating mutations (L861Q, G719S/A/C, S768I and others) make up 10 – 15 % of cases with mutant EGFR. Apart from that mutation T790M occurs in ~50 % of cases of aquired resistance to first generation EGFR-TK inhibitors. The European Society for Medical Oncology (ESMO) and American Society of Clinical Oncology (ASCO) recommend an EGFR mutation testing for selection of NSCLC patients who could benefit from anti-EGFR therapy.

Applications

The RealLine EGFR 2 M Kit is detecting following mutations:
• deletions and complex mutations in exon 19
• L858R

The RealLine EGFR 7R Kit is detecting the mutations:
• deletions and complex mutations in exon 19
• L858R
• L861Q
• G719X – detected but not genotyped G719S, G719A, G719C;
• S768I
• T790M

Indications for testing

  • Patients with tumors harboring either of these mutant forms of EGFR are extremely sensitive to the selective EGFR tyrosine kinase (TK) inhibitors gefitinib (IRESSA®) or erlotinib (TARCEVA®).

Sample Material

  • DNA extracted from fresh-frozen or formalin fixed paraffin embedded (FFPE) tumor tissue sections can be tested.

Real-Time PCR Detection Channels

  • FAM (495-520 nm)
  • EGFR Mutation and Control Mix
  • ROX (575-602 nm)
  • Internal Control IC

Tested cyclers and formats

  • iQ™ iCycler, iQ5™ iCycler, CFX96™ (Bio-Rad, USA)
  • AB 7500 (Applied Biosystems, USA)

Comments

The kit is adapted for use on real-time PCR instruments IQ™5 Cycler, CFX96 (Bio-Rad Laboratories, Inc., USA), DT96 (DNA-Technology, Russia), Rotor-Gene Q™ (Qiagen), StepOnePlus™ (Thermo Fisher Scientific).

The use of other real-time PCR devices and of appropriate reaction volumes have to be validated in the laboratory by the user.